A voluntary consensus standard is a standard that is specifically applicable to any aspect of the safety or effectiveness of a device. The FDA recognizes many voluntary standards, and compliance with these may be able to be used to help establish compliance with FDA requirements.
 
 
Information on the FDA standards program, together with a list of currently recognised standards can be accessed from here.
 
 
GEMAR can help you to determine which, if any of these voluntary standards apply to your medical device, and work with you to provide the necessary information to demonstrate how the device meets, or explain any deviation from, a voluntary standard.